Infusion Set With Anesthetic Compound

ABSTRACT

A method of constructing an infusion set, patch pump, or element thereof, comprising the steps of mixing at least two of a solvent, an anesthetic, and a lubricant, applying said mixture as a coating to at least one surface of an infusion set, patch pump, or element thereof, and substantially removing said solvent after coating to provide at least one of an anesthetic layer and a lubricant layer upon said infusion set, patch pump, or element thereof.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a division of U.S. Nonprovisional application Ser.No. 13/138,265, filed Jul. 26, 2011, which is a U.S. national stageapplication under 35 U.S.C. §371 of International Application No.PCT/US10/000190, filed Jan. 26, 2010, which claims the benefit under 35U.S.C. §119(e) of U.S. Provisional Patent Application No. 61/202,079,filed on Jan. 27, 2009, the entire content, disclosure and subjectmatter of these applications being expressly incorporated herein byreference.

FIELD OF THE INVENTION

The present invention relates generally to components and elements ofinfusion sets, including one or more set elements which can beimpregnated with, coated with, or otherwise configured to administer ananesthetic to minimize the risk of complications associated with the useof infusion sets, while maintaining a degree of comfort to the user.

BACKGROUND OF THE INVENTION

A large number of people, such as those suffering from conditions suchas diabetes, use some form of injection or infusion therapy, such asdaily insulin injections, to maintain close control of their glucoselevels. Currently, in the insulin treatment example, there are twoprincipal modes of daily insulin therapy. The first mode includessyringes and insulin pens. These devices are simple to use and arerelatively low in cost, but they require a needle stick at eachinjection, typically three to four times per day. The second modeincludes infusion pump therapy, which entails the purchase of an insulinpump that lasts for about three years. The initial cost of the pump canbe significant, but from a user perspective, the overwhelming majorityof patients who have used pumps prefer to remain with pumps for the restof their lives. This is because infusion pumps, although more complexthan syringes and pens, offer the advantages of continuous infusion ofinsulin, precision dosing and programmable delivery schedules. Thisresults in closer blood glucose control and an improved feeling ofwellness. More recently, patch pumps have been developed to provideusers with the advantages of insulin pumps but without the need forseparate infusion sets and tubing connectors.

As interest in intensive therapy increases, users typically look toinsulin pumps and patch pumps for improvements in the management oftheir condition. Therefore, interest in better pump-related therapy ison the rise. In this and similar examples, what is needed to fully meetthis increased interest are advanced, improved, and novel new componentsand elements of current and future insulin infusion sets, includingfeatures and elements to minimize the risk of complications associatedwith the use of infusion sets, while maintaining a degree of comfort tothe user.

Existing infusion sets, such as those used with insulin infusion pumps,are typically used for no more than 72 hours due to local siteirritation and the risk of infection. To minimize such risks,anti-microbial and/or anti-inflammatory drugs can be used. For example,U.S. Patent Publication No. 2007/0299409 of Whitboume et al. describesthe use of anti-microbial and anti-inflammatory drugs to reducecomplications associated with the use of infusion sets. However, thesemeasures alone cannot fully eliminate patient discomfort during use ofthe infusion set.

Accordingly, a need exists for advanced, improved, and novel newcomponents and elements of current and future insulin infusion sets andpatch pumps, that further provide one or more set elements which can beimpregnated with, coated with, or otherwise configured to apply oradminister an anesthetic to minimize the risk of complicationsassociated with the use of infusion sets, while maintaining a degree ofcomfort to the user.

SUMMARY OF THE INVENTION

An object of the present invention is to substantially address the aboveand other concerns, and provide advanced, improved, and novel newcomponents and elements of current and future insulin infusion sets andpatch pumps, that further provide one or more set elements which can beimpregnated with, coated with, or otherwise configured to apply oradminister an anesthetic to minimize the risk of complicationsassociated with the use of infusion sets and patch pumps, whilemaintaining a degree of comfort to the user.

Another object of the present invention is to provide an exemplary hub,needle and/or catheter which can be impregnated with, coated with, orotherwise configured to apply or administer an anesthetic to minimizethe risk of complications associated with the use of infusion sets,while maintaining a degree of comfort to the user.

Another object of the present invention is to provide an exemplaryadhesive for use with the hub, which can be impregnated with, coatedwith, or otherwise configured to apply or administer an anesthetic tominimize the risk of complications associated with the use of infusionsets, while maintaining a degree of comfort to the user.

Another object of the present invention is to provide such elementswhich can be impregnated with, coated with, or otherwise configured toapply or administer an anesthetic for a desired period of time, such asfor the entire expected life of the set, or for a shorter period.

Another object of the present invention is to provide an exemplarypolymer catheter material which can be impregnated with, coated with, orotherwise configured to apply or administer an anesthetic.

Another object of the present invention is to provide an exemplaryinfusion set tubing material which can be impregnated with, coated with,or otherwise configured to apply or administer an anesthetic.

Another object of the present invention is to provide an exemplarycannula and/or catheter lubricant material which can be impregnatedwith, coated with, or otherwise configured to apply or administer ananesthetic.

Another object of the present invention is to provide an exemplary hubadhesive material which can be impregnated with, coated with, orotherwise configured to apply or administer an anesthetic.

Another object of the present invention is to provide an exemplarypolymer coating material which can be impregnated with, coated with, orotherwise configured to dissolve over a period of time to apply oradminister an anesthetic.

Another object of the present invention is to provide an exemplarymetal, ceramic or composite matrix cannula which can be impregnatedwith, coated with, or otherwise configured to apply or administer ananesthetic.

Another object of the present invention is to provide the one or moreelements which can be impregnated with, coated with, or otherwiseconfigured to apply or administer an anesthetic wherein the anestheticcan be any one or more of amino esters (such as benzocaine), aminoamides (such as lidocaine and/or prilocaine), or other anestheticcompounds.

Another object of the present invention is to provide one or moreelements which can be impregnated with, coated with, or otherwiseconfigured to apply or administer an anesthetic and which can be used incombination with anti-microbial and/or anti-inflammatory drugs.

Another object of the present invention is to provide one or moreelements which can be impregnated with, coated with, or otherwiseconfigured to apply or administer an anesthetic and which can be used incombination with anti-microbial and/or anti-inflammatory drugs, whereinthe anti-microbial, anti-inflammatory, and anesthetic agents can beapplied to wetted portions of the infusion set or included in the bulkpolymer materials forming each article.

These and other objects are substantially achieved by providing aninfusion set, that further provides one or more set elements includingthe hub, hub adhesive, fluid line tubeset, connectors, catheters andinsertion needles which can be impregnated with, coated with, orotherwise configured to apply or administer an anesthetic to minimizethe risk of complications associated with the use of infusion sets andto increase user comfort. In addition to these elements of infusion setsas they exist today, still other functional parts and/or components thatexist in patch pumps, such as tubing, reservoirs, flexible reservoirs,cannula, etc., can also be impregnated with, coated with, or otherwiseconfigured to apply or administer an anesthetic to minimize the risk ofcomplications associated with the use of infusion sets and to increaseuser comfort.

These and other objects are also substantially achieved by providing amethod for manufacturing and using an infusion set and/or one or moreset elements which can be impregnated with, coated with, or otherwiseconfigured to apply or administer an anesthetic to minimize the risk ofcomplications associated with the use of infusion sets and to increaseuser comfort, wherein one or more elements can be provided with ormanufactured with an anesthetic, such as an anesthetic within thepolydialkylsiloxane lubricant formulation. Polydialkylsiloxanes can beapplied after dissolution in organic solvents, such as aliphatichydrocarbons, methylene chloride, or other chlorinated solvents. Theanesthetic can be included in the formulation by dissolution in thesolvent/polydialkylsiloxane mixture. The infusion set element(s) canthen be coated with the lubricant/anesthetic/solvent mixture by dipping,spraying, inkjet printing, or similar methods. After evaporation of thesolvent, a layer of the polydialkylsiloxane/anesthetic mixture remainson the surface of the element or device. The anesthetic can also beapplied after mixing with an aqueous or bioerodible polymer formulationwhich is then applied to the surface of the element or device throughany of the application methods described above. Still further, theanesthetic can be compounded into the polymer used to form any of thecomponents described above.

BRIEF DESCRIPTION OF THE DRAWINGS

The various objects, advantages and novel features of the preferredembodiments of the present invention will be more readily appreciatedfrom the following detailed description when read in conjunction withthe appended drawings, in which:

FIG. 1 is a perspective view of an infusion set which can include one ormore exemplary elements in accordance with an embodiment of the presentinvention; and

FIG. 2 is a flow chart illustrating exemplary manufacturing steps forimpregnating, coating or otherwise configuring the elements to apply oradminister the anesthetic.

Throughout the drawings, like reference numerals will be understood torefer to like parts, components and structures.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

The embodiments of the present device described below illustrate anumber of advanced, improved, and novel new components and elements ofcurrent and future insulin infusion sets, that further providesimplicity in manufacture and use improvements for both insulin andnon-insulin applications. Exemplary embodiments are presented inseparate descriptions, although the individual features of theseembodiments can be combined in any number of ways to meet the needs ofthe user.

As will be appreciated by one skilled in the art, there are numerousways of carrying out the examples, improvements and arrangements ofinfusion devices disclosed herein. Although reference will be made tothe embodiments depicted in the drawings and the following descriptions,the embodiments disclosed herein are not meant to be exhaustive of thevarious alternative designs and embodiments that are encompassed by thedisclosed invention.

The embodiments of the present device described below illustrate anumber of features and elements of an insulin infusion set, includingone or more set elements which can be impregnated with, coated with, orotherwise configured to apply or administer an anesthetic to minimizethe risk of complications associated with the use of infusion sets,while maintaining a degree of comfort to the user. A collection ofexemplary elements is shown by way of example in FIG. 1 which serves tointroduce the embodiments of the present invention described in greaterdetail below. FIG. 1 illustrates an exemplary infusion set 10 includingthe following features. As shown in FIG. 1, the exemplary infusion set10 can comprise a hub 12, a flexible catheter 14, a fluid line tubeset16 and a pump connector 18. Additional infusion set elements are omittedfor clarity. In the following description, a number of exemplaryembodiments of set elements are described in greater detail, which canbe provided for use with the exemplary infusion set 10. As noted above,one or more set elements can be impregnated with, coated with, orotherwise configured to apply or administer an anesthetic. A number ofexemplary elements will now be described individually in greater detail.

As noted above, existing infusion sets, such as those used with insulininfusion pumps, are typically used for no more than 72 hours due tolocal site irritation and the risk of infection. To minimize such risks,anti-microbial and/or anti-inflammatory drugs can be used. However,these measures alone do not fully eliminate patient discomfort duringuse of the infusion set.

To resolve such issues associated with conventional infusion setconstruction, design and implementation, the present invention compriseselements of an infusion set for the delivery, or infusion, of insulin orother medications to the subcutaneous tissue of a user, in which one ormore set elements can be impregnated with, coated with, or otherwiseconfigured to apply or administer an anesthetic. The infusion set 10typically comprises the hub 12 which includes the fixedly attachedcatheter 14, and the tubeset 16. The tubeset 16 connects the hub 12 toan infusion pump or other insulin supply (not shown) via a connector 18.In doing so, the tubeset 16 provides for fluid communication between theinfusion pump reservoir and the hub 12.

The hub 12 can be affixed to a patient's skin surface (not shown) usingan adhesive disposed on a lower surface of the hub. As shown in FIG. 1,the catheter 14 preferably protrudes from the lower surface of the hub12 at a substantially perpendicular angle, although embodiments of thepresent invention are not limited thereto. For example, angled infusionsets are known and may be used in the practice of the present invention.As described in greater detail below, the infusion set can be configuredas a disposable drug infusion set that releases an anesthetic at theinfusion site to improve user comfort. The anesthetic can be releasedfrom the needle or from catheter surfaces, catheter materials orotherwise, as well as from the adhesive materials used to attach theinfusion set to the user's skin.

In a first exemplary embodiment of the present invention, the catheter14 material, such as a polymer or similar material, can be impregnatedwith or have embedded therein, coated with, or otherwise configured tocontain and apply or administer the anesthetic or other materials. Thefirst exemplary embodiment of the present invention can be expanded toinclude the fluid line tubeset 16, which can also be impregnated with orhave embedded therein, coated with, or otherwise configured to containand apply or administer the anesthetic or other materials. In the caseof the tubeset, further design configurations can be provided to limitthe anesthetic or other materials to an interior of the tubeset.

The first exemplary embodiment of the present invention can be expandedto include a cannula and/or catheter 14 lubricant material which can beimpregnated with or have embedded therein, coated with, or otherwiseconfigured to contain and apply or administer the anesthetic or othermaterials. Exemplary lubricant materials can comprise a solvent appliedmixture of polydialkylsiloxanes and related compounds that are appliedto an exterior of the catheter 14 and/or insertion needle or insertiondevice (not shown).

The first exemplary embodiment of the present invention can be expandedto include the hub 12 adhesive material(s) which can be impregnated withor have embedded therein, coated with, or otherwise configured tocontain and apply or administer the anesthetic or other materials. Asknown to those skilled in the art, the placement of the set upon theuser's skin surface typically involves an adhesive material to securethe set upon the insertion site for the duration of the set life. Indoing so, the adhesive material typically contacts the skin surface ator near the insertion site, and therefore, provides a medium to containand apply or administer the anesthetic or other materials as desired.

The first exemplary embodiment of the present invention can be expandedto include a polymer coating material on the catheter 14 and/orinsertion device or needle (not shown) which can be. impregnated with orhave embedded therein, coated with, or otherwise configured to containthe anesthetic or other materials, and then dissolve over a period oftime to apply or administer the anesthetic or other materials. Theanesthetic or other materials can be embedded in such a biocompatiblepolymer coating, such as a hydrogel, which is disposed on at least aportion of the catheter 14 and/or the insertion device or needle (notshown). In doing so, the coating can be configured to dissolve over aperiod of time to release the active ingredients of the anesthetic orother materials over the useful life of the infusion set, or for anyshorter period thereof.

The first exemplary embodiment of the present invention can be expandedto include a rigid cannula (not shown) that serves the same function asthe flexible catheter 14. The rigid cannula can be comprised of anysuitable metal, ceramic or composite matrix cannula which can beimpregnated with or have embedded therein, coated with, or otherwiseconfigured to contain and apply or administer the anesthetic or othermaterials while serving the same function as the catheter 14.

In each of the exemplary embodiments of the present invention, theanesthetic which can be impregnated or embedded in and released by theinfusion set and set elements can be any one or more of amino esters(such as benzocaine), amino amides (such as lidocaine and/orprilocaine), or other anesthetic compounds. Further, each of theexemplary embodiments of the present invention described above can beused in combination with anti-microbial and/or anti-inflammatory drugs.Such anti-microbial, anti-inflammatory, and anesthetic agents can beapplied to wetted portions of the infusion set, such as the infusion settubing 16 and connectors 18, or can be included in the bulk polymermaterials forming each article or set element.

In each of the exemplary embodiments of the present invention, the rateat which the anesthetic is released from the device can be configuredsuch that it will provide the desired benefits for at least the entireexpected use of the set, or for a shorter period, such as a short periodover which a user is becoming comfortable with the set, or any variationin between.

As described above, an insulin infusion set can include one or more setelements including a hub, hub adhesive, fluid line tubeset, connectors,catheters and insertion needles which can be impregnated with, haveembedded therein, be coated with, or otherwise configured to administeran anesthetic to minimize the risk of complications associated with theuse of infusion sets and increase user comfort. By using the infusionset to deliver an anesthetic directly to the infusion site, andoptionally in combination with one or more of an anti-microbial,anti-inflammatory and antibiotic agent, the user's or patient'sdiscomfort can be reduced during the use of the infusion set. The usefullife of the infusion set can also be increased.

Through the selection and use of one or more of the infusions setelements described above, select locations of the embedded drug can bechosen to permit drug delivery closer to the area of concern, such asthrough the use of the adhesive patch that is in contact with the skin,the cannula lubricant touching the subcutaneous tissue and the entrythrough the skin, since drugs released from the tubing or inner walls ofthe cannula is more likely to perfuse in the tissue.

FIG. 2 is a flow chart illustrating exemplary manufacturing steps 20 forimpregnating, coating or otherwise configuring the elements to apply oradminister the anesthetic. An exemplary coating process can be achievedthrough a minimal number of steps, consisting of spraying, dipping, orotherwise applying the solvent/lubricant/anesthetic formulation andallowing the solvent to evaporate from the device. For example,materials such a polymer solvent or similar material, can be mixed withan anesthetic compound or similar material in a first step 22. As notedabove, the materials of step 22 can be used in the construction of theelements of the infusion set, or can be applied as a coating in asubsequent step 24. A finished product can then be achieved aftersolvent removal and/or after drying in step 26. Any of the exemplarysteps shown can be combined to ease manufacture.

For example, one or more elements of the infusion set can be providedwith or manufactured with an anesthetic, such as an anesthetic withinthe polydialkylsiloxane lubricant formulation. In one example,polydialkylsiloxanes can be applied after dissolution in organicsolvents in step 22, such as aliphatic hydrocarbons, methylene chloride,or other chlorinated solvents. The anesthetic can be included in theformulation by dissolution in the solvent/polydialkylsiloxane mixture.The elements can then be coated with the lubricant/anesthetic/solventmixture by dipping, spraying, inkjet printing, or similar methods instep 24. After evaporation of the solvent in step 26, a layer of thepolydialkylsiloxane/anesthetic mixture remains on the surface of theelement or device. The anesthetic can also be applied after mixing withan aqueous or bioerodible polymer formulation which is then applied tothe surface of the element or device through any of the applicationmethods described above. Still further, the anesthetic can be compoundedinto the polymer used to form any of the components described above.

Although only a few exemplary embodiments of the present invention havebeen described in detail above, those skilled in the art will readilyappreciate that many modifications are possible in the exemplaryembodiments without materially departing from the novel teachings andadvantages of this invention. Accordingly, all such modifications areintended to be included within the scope of this invention as defined inthe appended claims and equivalents thereof.

What is claimed is:
 1. A method of constructing an infusion set, patchpump, or element thereof, comprising the steps of: mixing at least twoof a solvent, an anesthetic, and a lubricant; applying said mixture as acoating to at least one surface of an infusion set, patch pump, orelement thereof; and substantially removing said solvent after coatingto provide at least one of an anesthetic layer and a lubricant layerupon said infusion set, patch pump, or element thereof.
 2. A method ofconstructing an infusion set, patch pump, or element thereof, as recitedin claim 1, wherein said step of mixing comprises mixing at least twoof: a polymer solvent; an anesthetic compound, comprising at least oneof amino esters, amino amides, and other anesthetic compounds; alubricant material; an anti-microbial material; and an anti-inflammatorymaterial.
 3. A method of constructing an infusion set, patch pump, orelement thereof, as recited in claim 1, wherein said step of applyingsaid mixture comprises at least one of: a spraying step wherein saidmixture is sprayed onto a surface of said infusion set, patch pump, orelement thereof; a dipping step wherein said infusion set, patch pump,or element thereof is dipped into said mixture; and an inkjet printingstep wherein said mixture is inkjet printed onto a surface of saidinfusion set, patch pump, or element thereof.
 4. A method ofconstructing an infusion set, patch pump, or element thereof, as recitedin claim 1, wherein said step of removing said solvent comprises: anevaporation step for allowing said solvent to evaporate from said coatedinfusion set, patch pump, or element thereof.
 5. A method ofconstructing an infusion set, patch pump, or element thereof, as recitedin claim 1, wherein said at least one of said anesthetic layer and saidlubricant layer is provided as a skin-contacting adhesive of saidinfusion set, patch pump, or element thereof configured to release saidanesthetic at an infusion site.
 6. A method of constructing an infusionset, patch pump, or element thereof, as recited in claim 1, wherein theat least one of said anesthetic layer and said lubricant layer isprovided as an external coating of a catheter of said infusion set,patch pump, or element thereof configured to release said anesthetic atany point between an infusion site and a catheter termination sitewithin said insertion site.
 7. A method of constructing an infusion set,patch pump, or element thereof, as recited in claim 1, wherein the atleast one of said anesthetic layer and said lubricant layer is providedas an internal coating of said infusion set, patch pump, or elementthereof configured to release said anesthetic at a catheter terminationsite within said insertion site.
 8. A method of constructing an infusionset, patch pump, or element thereof, as recited in claim 1, wherein theat least one of said anesthetic layer and said lubricant layer upon saidinfusion set, patch pump, or said element thereof is provided in abiocompatible polymer coating, such as a hydrogel, configured to releasesaid anesthetic over a period of time.
 9. A method of constructing aninfusion set, patch pump, or element thereof, as recited in claim 1,wherein said anesthetic layer and said lubricant layer comprise ananesthetic within a polydialkylsiloxane lubricant compound.
 10. A methodof constructing an infusion set, patch pump, or element thereof, asrecited in claim 9, wherein the step of mixing comprises: mixing saidpolydialkylsiloxanes with an organic solvent comprising at least one ofaliphatic hydrocarbons, methylene chloride, and other chlorinatedsolvents; and dissolving said anesthetic in saidsolvent/polydialkylsiloxane mixture.
 11. A method of constructing aninfusion set, patch pump, or element thereof, as recited in claim 1,wherein the step of mixing comprises mixing said anesthetic with atleast one of an aqueous and bioerodible polymer formulation.
 12. Amethod of applying or administering an anesthetic at an infusion site,comprising the steps of: providing at least one of a hub, catheter orcannula of an infusion set or patch pump with an anesthetic; andaffixing the infusion set or patch pump to the skin of a patient torelease the anesthetic at an insertion site of said catheter or cannula.13. A method of applying or administering an anesthetic at an infusionsite as claimed in claim 12, wherein said anesthetic is provided in abiocompatible polymer coating, such as a hydrogel, configured forrelease at said insertion site over time.
 14. A method of applying oradministering an anesthetic at an infusion site as claimed in claim 12,wherein said anesthetic is provided as a skin-contacting, adhesive layerdisposed upon an outer surface of said hub for release at said insertionsite.
 15. A method of applying or administering an anesthetic at aninfusion site as claimed in claim 12, wherein said anesthetic isprovided as a layer disposed upon an inner surface of said hub, catheteror cannula for release at a termination site within said insertion site.16. A method of applying or administering an anesthetic at an infusionsite as claimed in claim 12, wherein said anesthetic is provided as aconstruction material of said hub, catheter or cannula for release atboth said insertion site and a termination site within said insertionsite.
 17. A method of applying or administering an anesthetic at aninfusion site as claimed in claim 12, wherein said anesthetic comprisesan anesthetic within a polydialkylsiloxane lubricant compound.
 18. Amethod of applying or administering an anesthetic at an infusion site asclaimed in claim 12, wherein said anesthetic comprises at least one ofamino esters, amino amides, and other anesthetic compounds.
 19. A methodof applying or administering an anesthetic at an infusion site asclaimed in claim 12, wherein said at least one surface of said hub,catheter or cannula is further provided with at least one of a lubricantmaterial, an anti-microbial material, and an anti-inflammatory materialwith said anesthetic.